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The Effects of an Antioxidant Formulation on Ocular Blood Flow

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ScienceBased Health
ClinicalTrials.gov Identifier:
NCT01930487
First received: August 9, 2013
Last updated: October 13, 2016
Last verified: January 2016
  Purpose

The objective is to evaluate the effects of an antioxidant formula versus placebo on ocular blood flow in a randomized double-blind, crossover design.

Based upon preliminary data, it is hypothesized that a dietary supplement containing a variety of ingredients with antioxidant properties will, compared to placebo, increase ocular perfusion pressure, retrobulbar, retinal capillary and choroidal blood flow, and maintain these effects over the course of the treatment period.


Condition Intervention
Primary Open Angle Glaucoma
Dietary Supplement: dietary supplement with antioxidants
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effects of an Antioxidant Formulation on Intraocular Pressure, Ocular Perfusion Pressure, Retrobulbar, Retinal Capillary and Choroidal Blood Flow

Resource links provided by NLM:


Further study details as provided by ScienceBased Health:

Primary Outcome Measures:
  • Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)

  • Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF)


Secondary Outcome Measures:
  • Change in Ocular Perfusion Pressure [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in ocular perfusion pressure (2/3 Mean arterial pressure - intraocular pressure)

  • Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

  • Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

  • Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

  • Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

  • Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

  • Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

  • Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

  • Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI)

  • Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)

  • Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)

  • Change in Nasal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in nasal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)

  • Change in Temporal Posterior Ciliary Artery Blood Flow - Vascular Resistance (Ratio) [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in temporal posterior ciliary artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI)

  • Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

  • Change in Ophthalmic Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in ophthalmic artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

  • Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

  • Change in Central Retinal Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in central retinal artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

  • Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

  • Change in Nasal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in nasal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

  • Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

  • Change in Temporal Posterior Ciliary Artery Peak Systolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in temporal posterior ciliary artery peak systolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

  • Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

  • Change in Ophthalmic Artery End Diastolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in ophthalmic artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

  • Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

  • Change in Central Retinal Artery End Diastolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in central retinal artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

  • Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

  • Change in Nasal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in nasal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

  • Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients with type 2 diabetes

  • Change in Temporal Posterior Ciliary Artery End Diastolic Blood Flow Velocity (cm/s) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in temporal posterior ciliary artery end diastolic blood flow velocity (cm/s) using color Doppler imaging (CDI) in patients without type 2 diabetes

  • Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes

  • Change in Ophthalmic Artery Blood Flow - Vascular Resistance (Ratio) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in ophthalmic artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes

  • Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes

  • Change in Central Retinal Artery Blood Flow - Vascular Resistance (Ratio) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in central retinal artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes

  • Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes

  • Change in Nasal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in nasal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes

  • Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients with type 2 diabetes

  • Change in Temporal Posterior Artery Blood Flow - Vascular Resistance (Ratio) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in temporal posterior artery blood flow - vascular resistance (ratio) using color Doppler imaging (CDI) in patients without type 2 diabetes

  • Change in Ocular Perfusion Pressure - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients with type 2 diabetes

  • Change in Ocular Perfusion Pressure - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in Ocular perfusion pressure in patients without type 2 diabetes

  • Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes

  • Change in Superior Retinal Capillary Blood Flow (% Zero Pixels) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in superior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes

  • Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients with type 2 diabetes

  • Change in Inferior Retinal Capillary Blood Flow (% Zero Pixels) - No DM [ Time Frame: baseline and 30 days ] [ Designated as safety issue: No ]
    change (post-treatment - pre-treatment) in inferior retinal capillary blood flow (% zero pixels or % avascular tissue) using Heidelberg Retinal Flowmeter (HRF) in patients without type 2 diabetes


Enrollment: 47
Study Start Date: August 2013
Study Completion Date: August 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: supplement w/ antioxidants then placebo
dietary supplement with antioxidants, followed by placebo supplement
Dietary Supplement: dietary supplement with antioxidants
Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids
Other Name: Optic Nerve Formula
Dietary Supplement: Placebo
Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants
Experimental: placebo then supplement w/ antioxidants
placebo supplement, followed by dietary supplement with antioxidants
Dietary Supplement: dietary supplement with antioxidants
Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids
Other Name: Optic Nerve Formula
Dietary Supplement: Placebo
Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 30 years or older.
  • Confirmed diagnosis of open angle glaucoma by glaucoma specialist in the study eye, as evidenced from criteria representative of glaucomatous optic nerve damage such as specific optic disc or retinal nerve fiber layer structural abnormalities and/or visual field abnormalities.
  • Best corrected visual acuity at 20/60 or better in study eye.
  • Willingness to avoid caffeine and smoking for 12 hours before and during the study visits.

Exclusion Criteria:

  • History of acute angle-closure or a narrow, occluding of anterior chamber angle by gonioscopy.
  • History of chronic or recurrent inflammatory eye diseases or signs of intraocular trauma and/or unreliable applanation tonometry.
  • Severe, unstable or uncontrolled cardiovascular, renal or pulmonary disease
  • History of/or current renal or hepatic impairment.
  • History of/or current bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second or third degree atrioventricular block, or cardiogenic shock.
  • Recent surgery or surgery planned near study timeline
  • History of bleeding disorder
  • Use of blood thinning medications
  • Use of specified dietary supplements for three weeks prior to study entry and throughout study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930487

Locations
United States, Indiana
Glick Eye Institute, Ocular Vascular Research Center, Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
ScienceBased Health
Investigators
Principal Investigator: Alon Harris, PhD Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Director Clinical Research Glick Eye Institute, Indiana University Medical Center
  More Information

Responsible Party: ScienceBased Health
ClinicalTrials.gov Identifier: NCT01930487     History of Changes
Other Study ID Numbers: 007 
Study First Received: August 9, 2013
Results First Received: May 31, 2016
Last Updated: October 13, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by ScienceBased Health:
Primary open angle glaucoma
intraocular pressure
ocular perfusion pressure
retrobulbar blood flow
retinal capillary blood flow
choroidal blood flow

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 05, 2016